(125 days)
No
The 510(k) summary describes a bone graft substitute material and its properties, with no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is a bone graft substitute intended to fill and augment bony defects, facilitating complete repair of the defect by providing a scaffold for new bone growth. This direct interaction with the body to restore function qualifies it as a therapeutic device.
No
The device is described as a bone graft substitute used to fill and/or augment bone defects, promoting new bone growth. It is a therapeutic device, not one for diagnosing conditions.
No
The device description clearly states that the device is made of degradable bioactive glass and comes in different size cylinders, blocks, and morsels. This indicates a physical implant, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The INION BIORESTORE™ implants are described as bone graft substitutes that are implanted into the body to fill bony voids or gaps. They are used in vivo (within the living body).
- Intended Use: The intended use clearly states that the implants are used to fill and/or augment defects within the body, not to test specimens taken from the body.
The provided information describes a surgical implant used for bone repair, which falls under the category of medical devices used in vivo, not IVDs.
N/A
Intended Use / Indications for Use
The Inion BioRestore™ implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.
Product codes
LYC
Device Description
Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft substitute used either separately or in conjunction with autogenous or allograft bone. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect.
Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. Inion BioRestore™ implants degrade in vivo in six months based on pre-clinical data. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-collagenous.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraosseous, oral and craniomaxillofacial defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
NovaBone ® (K000149), PerioGlass ® Bioglass ® Bone Graft Particulate (K040278), Chronos-beta-TCP (K053022), Theriridge™ Block, Bone Graft Substitute (K023998), Interpore 200 Porous Hydroxyapatite (K860983)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image shows a logo with the word "INION" in large, bold letters. Below the main word, there is a smaller tagline that reads "Intelligent Solution." The background appears to be textured or slightly grainy, giving the logo a distinct look.
510(k) SUMMARY
Inion BioRestore™
JUL 2 4 2007
Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person Kati Marttinen, Regulatory Affairs Specialist Phone: +358 10 830 6600 Fax: +358 10 830 6691 kati.marttinen@inion.com
Establishment registration number 9710629
Trade name of the device Inion BioRestore™
Device classification and product code
Class II (Special controls) Classification Panel: Dental Product Code: LYC Common name: Osteoconductive and osteostimulative bone void filler; Synthetic resorbable bone graft material Regulation number: 872.3930
Predicate devices
NovaBone ® (K000149) PerioGlass ® Bioglass ® Bone Graft Particulate (K040278) Chronos-beta-TCP (K053022) Theriridge™ Block, Bone Graft Substitute (K023998) Interpore 200 Porous Hydroxyapatite (K860983)
Conformance with performance standards
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
Inion Oy www.inion.com
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Image /page/1/Picture/0 description: The image shows the logo for INION. The word "INION" is written in large, bold, white letters. Below the word "INION" is the phrase "Intelligent Solution" written in a smaller, italicized font. The background of the image is black.
510(k) SUMMARY
Inion BioRestore™
$\frac{282}{K020784}$
Device description and principles of operation
Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft substitute used either separately or in conjunction with autogenous or allograft bone. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect.
Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. Inion BioRestore™ implants degrade in vivo in six months based on pre-clinical data. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-collagenous.
Indications for use
The Inion BioRestore™ implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.
Substantial equivalence to marketed products
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation properties, bioactive, osteoconductive and osteoproductive properties of Inion BioRestore™ implants are substantially equivalent with the predicate Class II devices, when used in the indications for use described above, because the differences between Inion BioRestore™ and the predicate devices do not raise new questions of safety and effectiveness. The calcium-based predicate devices are substantially equivalent predicate devices by being solid synthetic blocks, cylinders and particulates for bone filling in dental and CMF applications, and the use of these devices results in the formation of HA layer and eventually new bone growth to the implant site. All implants are used for non load bearing applications.
Inion Oy www.inion.com
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kati Marttinen Regulatory Affairs Specialist Inion Oy Lääkärinkatu 2 Tampere. Finland 33520
JUL & 4 2007
Re: K070784
Trade/Device Name: Inion BioRestore™ Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 5, 2007 Received: June 11, 2007
Dear Ms. Marttinen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Ms. Kati
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
| 510(k) Number: | K070784 |
|---|---|
| Device Name: | Inion BioRestore™ |
The INION BIORESTORE™ implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suze Punne
(Division Sign-Off) (Civision Sign-Om)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
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